by dr g n singh - pharmaceuticals export promotion council
TRANSCRIPT
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As per the Drugs and Cosmetics Act 1940, the Indian Pharmacopoeia is the legally recognized book of Standards for the quality of drug substances and preparations included therein.
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The Indian Pharmacopoeia Commission has been established as an Autonomous Institution under Ministry of Health & Family Welfare on 09th Dec. 2004.
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To promote public health in India by bringing out authoritative and officially accepted standards for quality of drugs including active pharmaceutical ingredients, excipients and dosage forms, used by health professionals, patients and consumers.
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To promote the highest standards for drugs for use in humans and animals within practical limits of the technologies available for manufacturing and analysis.
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To bring new editions and supplements of the Indian Pharmacopoeia at regular intervals
To accelerate the process of preparation, certification and distribution of IP Reference Substances
To establish working relations with other Pharmacopoeial Agencies
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To develop comprehensive monographs for drugs to be included in the Indian Pharmacopoeia, including active pharmaceutical ingredients, excipients and dosage forms as well as medical devices, and to keep them updated by revision on a regular basis.To develop monographs for herbal drugs, both raw drugs and extracts/formulations therefroms.To accord priority to monographs of drugs included in the National Essential Drugs List and their dosage forms.
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To prepare monographs for products that have normally been in the market for not less than 2 years except for certain special categories of new drugs like antiretrovirals, antituberculosis and anticancer drugs and their formulations introduced more recently, which may be accorded priority attention.
To give special attention to the methods of manufacture used by the indigenous industry in selecting the pharmacopoeial tests for monitoring the toxic impurities of the concerned drug.
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To take note of the different levels of sophistication in analytical testing/ instrumentation available while framing the monographs.To accelerate the process of preparation, certification and distribution of IP Reference Substances, including the related substances, impurities and degradation products.To collaborate with pharmacopoeias like the Ph Eur, BP, USP, JP, ChP and International Pharmacopoeia with a view to harmonizing with global standards
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To review existing monographs periodically with a view to deleting obsolete ones and amending those requiring upgradation / revision.
To organize educational programs and research activities for spreading and establishing awareness on the need and scope of quality standards for drugs and related articles / materials.
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The Office of the Commission is situated at the Central Indian Pharmacopoeia Laboratory Campus, Sector-23, Rajnagar, Ghaziabad-201 002, India.
It is an ultra modern premise having state-of-the art infrastructure and excellent facilities.
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Indian Pharmacopoeia
Commission(IPC)
IPC Secretariat
CIPLLab
Governing Body 10 Members
(Notified on 22-03-05)
General Body 19 Members
(Notified on 22-03-05)
Scientific Body 23 Experts
(Notified on 22-11-05)
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SCIENTIFIC BODY - Consists of 23 Experts
Executive Committee 01 (Members 05)
Expert Committees 21 (Members 4 to 5)
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IP Addendum 2005Plan for distribution and marketingWeb-site(www.ipc.gov.in)
Work plan for IPRSPriority items (133)IPRS Label Scheme
Identified itemsActive DrugsDosage FormsNational Priority Drugs
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UpgradationUpgradation
General Notices contents
Monographs : 1265
Appendices : 300
Veterinary Monographs : 80
General Analytical Methods : 300
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Additions Additions Monographs
Vaccines and OtherBiological Products : 51
Biotechnological Products : 12
Blood and Blood Products : 32
Medicinal Plants : 20
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Monographs
New DrugsActive : 100Formulations : 300
Antituberculosis/Antiasthmatic Drugs : 35
Antiretroviral Drugs : 20
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New edition of Indian Pharmacopoeia in 2007
Early availability of IP Reference Substances
International collaborations with USP, BPC, EDQM, WHO etc for acceptance of IP globally